Cleared Traditional

K031374 - BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 (FDA 510(k) Clearance)

K031374 · Besmed Health Business Corp · Neurology device
Nov 2003
Decision
212d
Days
Class 2
Risk

K031374 is an FDA 510(k) clearance for the BESMED VARIOUS MODELS OF TENS, BE-550/BE-660. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).

Submitted by Besmed Health Business Corp (Hsin Chu City, TW). The FDA issued a Cleared decision on November 28, 2003, 212 days after receiving the submission on April 30, 2003.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K031374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date November 28, 2003
Days to Decision 212 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.5890